The invention relates to devices and methods for shrinking collagen in body tissue.
Gastro esophageal reflux disease or xe2x80x9cGERDxe2x80x9d, female stress incontinence or xe2x80x9cFSIxe2x80x9d and vesicouretal reflux or xe2x80x9cVURxe2x80x9d affect millions of people in the United States and many more overseas. Pharmaceuticals, such as omeprazole, marketed as Prilosec(copyright) by AstraMerck of Wayne, Pa., or rabeprazole sodium, marketed as Aciphex(copyright) by Esai Co. of Titusville, N.J. are able to palliate but not cure GERD and usually must be taken for the rest of the person""s lifetime. Surgical treatment of GERD, a procedure called Nissen Fundoplication, is highly invasive, requires general anesthesia, a costly hospital stay and extensive recuperation and creates significant adverse effects, including infections and persistent pain. Likewise, surgical treatments for FSI, including slings, staples, screws and other devices, as well as the injection of collagen, such as manufactured by the Collagen Corporation and distributed as Contigen(copyright) by C. R. Bard, Inc. of Murray Hill, N.J., are invasive, entail substantial cost and frequently do not provide lasting relief.
It would be desirable to be able to treat GERD, VUR, FSI and other conditions in a minimally invasive, non-surgical procedure that could be rendered in a few minutes in a hospital outpatient department or outpatient surgical center, as well as in a physician""s office, without general anesthesia, at modest cost and with little recuperation time.
Collagen present in tissue surrounding a hollow organ, body cavity, duct or naturally occurring or surgically created passage can be treated with a device embodying the present invention to tighten the tissue around the hollow organ, cavity, duct or passage, such as the esophagus in the area of the sphincter or the female urethra near the bladder neck, so as to alleviate conditions such as gastro-esophageal reflux disease, female stress incontinence, vesico-uretal reflux, and the like. A balloon made of a biocompatible, flexible (non-compliant) or elastic (compliant) material is joined to the distal end of a flexible catheter provided with a rounded, atraumatic, closed distal end. The proximal end of the catheter is provided with a handpiece for manipulating the catheter. One or more ports in the catheter, and within the balloon, provide fluid communication from the catheter into the balloon. A fluid inflow tube joined to the catheter in or near the distal end of the handpiece, provides a passageway for a fluid to be infused through the fluid inflow tube into the catheter to inflate the balloon. An optional vent valve in or near the distal end of the handpiece, permits air to escape when fluid is infused into the catheter to inflate the balloon.
A plurality of small, flexible tubes are situated on the exterior of the balloon. The tubes terminate preferably at about the balloon""s largest outside diameter when expanded. The proximal ends of the tubes pass through the wall of the catheter and open into its inner lumen, creating a channel for fluid flow therethrough. The openings in the catheter through which the tubes extend are sealed with an adhesive or thermal bonding. The distal end portions of the tubes are free, i.e., not attached to the external surface of the balloon.
An optical fiber is slidably disposed within each of the tubes. The distal ends of the optical fibers can be beveled or sharpened if desired to facilitate penetration into tissue. The optical fibers extending from the proximal ends of the tubes are joined into a bundle within the catheter by enclosing the same in a casing, for example, made of a heat shrinkable film, or in a sleeve made of a flexible plastic material, as known in the art. The bundle of optical fibers extends through the handpiece, and can be connected to a source of high intensity light or coherent light such as a laser.
A slidable control button, which may be engaged by the operator""s thumb, is disposed within a slide channel on the exterior of the handpiece. The portion of the button which extends through the slide is attached to a metal sleeve which, in turn, is attached to and surrounds the bundle of optical fibers. When the button is advanced a predetermined distance, an audible xe2x80x9cclickxe2x80x9d is created by a ratchet mechanism, and the optical fibers are extended a like distance out of the distal ends of the tubes in which they are disposed.
The above described device is slidably disposed within a flexible, retractable, protective sheath, which has markings at predetermined intervals from its distal end. The catheter itself also has markings at the same intervals beginning at the proximal end of the sheath. In use, the catheter/balloon/tube assembly, contained within the sheath, may be inserted into a hollow organ, duct, cavity or passage to a selected position, which has been earlier determined in any convenient manner.
When placed, the protective sheath is retracted a distance sufficient to expose all or a desired portion of the balloon. A biocompatible fluid is then infused to inflate the balloon, which urges the distal ends of the tubes up against the inner surface of the hollow organ, cavity, duct or passage to be treated. Since the distal end portions of the tubes are not affixed to the balloon, they extend away from the balloon at a greater angle than if they were fully affixed to the balloon.
The optical fibers are introduced into the tissue a desired distance by the operator""s thumb advancing the control button a like distance. For example, in the treatment of GERD or FSI, the device would be positioned in the esophagus at or near the level of the sphincter or in the female urethra proximal to the bladder neck, respectively. To avoid thermal damage to the sensitive inner lining (mucosa) of the esophagus or urethra, light energy is not transmitted through the optical fibers until they have been inserted through the mucosa into the tissue. Light energy is then emitted for a time sufficient to shrink the tissue, causing mechanical cross linkage of collagen and internal scarring of the tissue. The result of this treatment a is tightening of the muscle tissue surrounding the sphincter or the urethra.
When light energy of a desired wavelength has been emitted at a desired level and for a sufficient amount of time, the fibers are retracted, the balloon is deflated, the protective sheath is advanced over the catheter/balloon/tube assemblage and the device is removed.